Sara Levy

CSV Expert, Engineering & Validation Project Manager

Sara has a B.Sc. in Industrial and Management Engineering with more than 28 years of experience in the field of Information Systems and Quality Assurance serving a variety of industries including Oil & Gas, Telecommunications, Software Development and in the Pharmaceutical, Biotech and Device manufacturing industries. Highly proficient in Computerized Systems Validation and Data Integrity compliance according to 21 CFR Part 11, Annex 11, and MHRA Regulations. An expert in authoring and reviewing the full spectrum of CSV deliverables for a variety of systems such as Control Systems, Company-wide systems, QC Analytical Lab, Quality Management Systems, SaaS, and bespoke developed applications. Highly skilled in training and mentoring IT staff, business SMEs and Senior Managers on CSV, Data Integrity, and Data Governance practices, as well as Quality Management Systems. Participated as a speaker during Quality and Validation conferences including ISPE Indian chapter. Sara has a diverse international background, - having worked in Venezuela, Israel, United States, Canada, and Germany, - that enables her to properly communicate and establish a professional rapport with co-workers and variety of clients.